FDA WARNING_LETTER - BioLab Sciences, Inc. - September 03, 2021

FDA WARNING_LETTER for BioLab Sciences, Inc. on September 03, 2021. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for BioLab Sciences, Inc. on September 03, 2021. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

21 CFR 211.42(c)(10)(i)

FD&C Act 501(a)(2)(B)

42 U.S.C. 262(a)(3)

21 CFR 211.166(a)

21 CFR 1271.10(a)(2)

21 CFR 211.160(b)

21 U.S.C. 355(i)

42 U.S.C. 262(i)

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Record Information

Company

BioLab Sciences, Inc.

Inspection Date

September 3, 2021

Product Type

Biologics

Office

Office of Biological Products Operations - Division I

People

ID: 2a8a0eda-5bd6-4c33-8318-8812d73c0465

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